Quality Engineer - Medical Devices at Engineering Resource Group

Description

• Permanent position for a Quality Engineer for medical device manufacturing, performing inspections and audits.
• Participate on cross functional product teams for the development of new and modified orthopedic systems.
• Specify, develop, and validate quality control methodology, quality planning, and test equipment at the supplier's process.
• Provide quality control technical expertise and leadership to operations and development with respect to design requirements, dimensioning and inspection techniques, and capabilities
• Assist with the development of the design history file and all included records.
• Assist with project milestones such as design reviews, phase reviews, risk analysis, drawing reviews, etc.
• Perform periodic documented examination and verification of activities, records, and processes of any given quality system to determine the effectiveness and dependability of such system.
• Evaluate internal processes and results comply with the requirements of procedures, quality, and regulatory requirements.
• Develop audit plans and schedules.
• Participate in quality audits, identify gaps and issues where a department is meeting requirements, as well as identify opportunities for improvement.
• Develop audit reports, assist with follow up audits as required.

Requirements

• BS Engineering
• Minimum 5 years experience with medical device manufacturing and quality assurance.
• Knowledge of FDA Quality Systems Regulations and International ISO quality systems standard.
• Understanding and interpretation of engineering drawings and specifications, GD&T tolerance schemes.
• Comprehend quality planning tools such as first article inspections, process failure modes and effects analysis, measurement system analysis, inspection planning.
• Understanding of manufacturing processes.
• Understanding of FDA Quality System's Regulations and ISO 13485 standard.
• Understanding of the regulatory design control process.
• Aptitude to learn new processes and software applications.